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Emadine

Novartis

Ögondroppar, lösning 0,5 mg/ml
(Lösning, färglös till blekgul)

Antiallergiskt medel för lokal behandling av allergisk konjunktivit

Aktiv substans:
ATC-kod: S01GX06
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Emedastin

Miljörisk: Risk för miljöpåverkan av emedastin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att emedastin är persistent, då data saknas.
Bioackumulering: Emedastin har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R)) / (365*P*V*D*100) = 0.000035 μg/L

PEC = 0.000035 μg/L

Where:

A = 0.23302 kg (total amount of API sold in Sweden year 2019, data from IQVIA).

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 ×106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae: no data available


Crustacean (Daphnia magna): no data available


Fish: no data available


Other ecotoxicity data: No data available

PNEC derivation:

No PNEC can be calculated since there is no environmental toxicity data available 


Environmental risk classification (PEC/PNEC ratio)

The calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: “Risk of the environmental impact of Emedastine cannot be excluded, since no ecotoxicity data are available.”

However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/44447/00 corr2), the use of Emedastine is unlikely to represent a risk for the environment, given that its predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.


Degradation 

Biotic degradation

Ready degradability: no data available

Justification of chosen degradation phrase:

As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of emedastine cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

LogKow = 2.03 (method unknown) (Clarke’s Analysis of Drugs and Poisons, 2017)

Justification of chosen bioaccumulation phrase:

As the LogKow remains below the trigger level for a bioaccumulative substance of 4.0, the following statement is used for emedastine: ‘Emedastine has a low potential for bioaccumulation.’

Excretion (metabolism)

Following oral administration of emedastine, the drug is metabolized in the liver principally to 5- and 6-hydroxyemedastine, metabolites that appear to undergo further oxidation to form 5′-oxo analogs.112 Emedastine N-oxide also is formed as a minor metabolite.

In adults, about 44% of an oral dose is recovered in the urine within 24 hours.1 About 3.6% of an orally administered dose is excreted in urine as parent drug; 5- and 6-hydroxyemedastine and their conjugates also are recovered in urine. (AHFS Drug Information, 2017).


PBT/vPvB assessment

Emedastine has a low potential for bioaccumulation given that its octanol-water partition coefficient is below the trigger value for a bioaccumulative substance. Nevertheless, given that data is not available for the other two “PBT” properties of persistence and toxicity, an absolute PBT assessment is not possible.


References